Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 940-300-7 | CAS number: 1339119-15-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was conducted between 31 October 2013 and 26 November 2013.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study is considered to be a reliability 1 as it has been conducted according to OECD Test Guideline 423 using the Acute Toxic Class Method and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-[(8R)-tricyclo[5.2.1.0²,⁶]decan-8-yl]acetaldehyde; 2-[(8S)-tricyclo[5.2.1.0²,⁶]decan-8-yl]acetaldehyde
- EC Number:
- 940-300-7
- Cas Number:
- 1339119-15-1
- Molecular formula:
- C12H18O
- IUPAC Name:
- 2-[(8R)-tricyclo[5.2.1.0²,⁶]decan-8-yl]acetaldehyde; 2-[(8S)-tricyclo[5.2.1.0²,⁶]decan-8-yl]acetaldehyde
- Test material form:
- other: liquid
- Details on test material:
- Identification: IFF TM 11-213
Storage Conditions: Approximately 4 °C in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Animals and Animal Husbandry
Female Wistar (RccHan™:WIST) strain rats were supplied by Harlan Laboratories UK Ltd., Oxon, UK. On receipt the animals were randomly allocated to cages. The females were nulliparous and non pregnant. After an acclimatization period of at least five days the animals were selected at random and given a number unique within the study by indelible ink marking on the tail and a number written on a cage card. At the start of the study the animals were eight to twelve weeks of age. The body weight variation did not exceed ± 20 % of the body weight of the initially dosed animal.
The animals were housed in groups of up to three in suspended solid floor polypropylene cages furnished with woodflakes. With the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to mains drinking water and food (2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK) was allowed throughout the study. The diet, drinking water and bedding were routinely analyzed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 19 to 25 °C and 30 to 70 % respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- Test Item Formulation and Experimental Preparation
For the purpose of the 2000 mg/kg dose level, the test item was used as supplied. The specific gravity was determined and used to calculate the appropriate dose volume for the required dose level. For the purpose of the 300 mg/kg dose level, the test item was freshly prepared, as required, as a solution in arachis oil BP. Arachis oil BP was used because the test item did not dissolve/suspend in distilled water.
The test item was formulated within two hours of being applied to the test system. It is assumed that the formulation was stable for this duration.
No analysis was conducted to determine the homogeneity, concentration or stability of the test item formulation. This is an exception with regard to GLP and has been reflected in the GLP compliance statement. - Doses:
- A group of three fasted females was treated with the test item at a dose level of 300 mg/kg body weight. Based on the results from this dose level, further groups of fasted females were treated at dose levels of 300 or 2000 mg/kg body weight. Dosing was performed sequentially.
The test item was administered orally undiluted at a dose level of 2000 mg/kg and as a solution in arachis oil BP at a dose level of 300 mg/kg. - No. of animals per sex per dose:
- 3 female rats per dose level
- Control animals:
- no
- Details on study design:
- Procedure
In the absence of data regarding the toxicity of the test item, 300 mg/kg was chosen as the starting dose.
All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted body weight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each group to confirm the survival of the previously dosed animals.
The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for up to fourteen days.
Individual body weights were recorded prior to dosing and seven and fourteen days after treatment or at death.
At the end of the observation period the surviving animals were killed by cervical dislocation. All animals were subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
Data evaluations included the relationship, if any, between the exposure of the animal to the test item and the incidence and severity of all abnormalities including behavioral and clinical observations, gross lesions, body weight changes, mortality and any other toxicological effects.
Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test item was made.
The results were also evaluated according to Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Animals treated at a dose level of 2000 mg/kg were killed for humane reasons, during the day of dosing, due to the occurrence of clinical signs of toxicity that exceeded the severity limit set forth in the UK Home Office Project Licence or found dead one day after dosing. One of the second group of animals, treated at a dose level of 300 mg/kg, was found dead one day after dosing.
- Clinical signs:
- other: Signs of systemic toxicity noted at a dose level of 2000 mg/kg were ataxia, lethargy, hunched posture, prostration, labored respiration, decreased respiratory rate, occasional body tremors, hypothermia and pallor of the extremities. Hunched posture was n
- Gross pathology:
- Abnormalities noted at necropsy of animals that were humanely killed or died during the study were pale liver, patchy pallor of the liver, pale or dark kidneys, clear liquid present in the stomach, hemorrhage and epithelial sloughing of the gastric mucosa and hemorrhage of the non-glandular epithelium of the stomach. No abnormalities were noted at necropsy of animals that were killed at the end of the study.
Any other information on results incl. tables
Mortality Data
Dose Level mg/kg |
Sex |
Number of Animals Treated |
Deaths During Day of Dosing |
Deaths During Period After Dosing |
Deaths |
||||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8-14 |
||||
300 |
Female |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/3 |
Female |
3 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1/3 |
|
2000 |
Female |
3 |
0 |
0 |
0 |
2* |
1 |
|
|
|
|
|
|
|
3/3 |
*= Animals killed for humane reasons due to the occurrence of clinical signs of toxicity that exceeded the severity limit set forth in the UK Home Office Project Licence
Individual Clinical Observations - 300 mg/kg
Dose Level mg/kg |
Animal Number and Sex |
Effects Noted After Dosing |
Effects Noted During Period After Dosing |
||||||||||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
300 |
1-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1-1 Female |
0 |
0 |
0 |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1-2 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-1 Female |
0 |
0 |
0 |
0 |
X |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3-2 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0= No signs of systemic toxicity
H = Hunched posture
X = Animal dead
Individual Clinical Observations - 2000 mg/kg
Dose Level mg/kg |
Animal Number and Sex |
Effects Noted After Dosing |
Effects Noted During Period After Dosing |
||||||||||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
2000 |
2-0 Female |
0 |
AL |
HA |
HA |
X |
|
|
|
|
|
|
|
|
|
|
|
|
|
2-1 Female |
0 |
0 |
PrRl |
PrRlRd |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2-2 Female |
0 |
0 |
PrRl |
PrRlRd |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0= No signs of systemic toxicity
A = Ataxia
L = Lethargy
H = Hunched posture
Pr = Prostration
Rl = Labored respiration
Rd =Decreased respiratory rate
To =Occasional body tremors
Ho = Hypothermia
E = Pallor of the extremities
X = Animal dead
*= Animals killed for humane reasons due to the occurrence of clinical signs of toxicity that exceeded the severity limit set forth in the UK Home Office Project Licence
Individual Body Weights and Body Weight Changes - 300 mg/kg
Dose Level mg/kg |
Animal Number and Sex |
Body Weight (g) at Day |
Body Weight (g) |
Body Weight Gain (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
|||
300 |
1-0 Female |
152 |
174 |
186 |
|
22 |
12 |
1-1 Female |
160 |
178 |
192 |
|
18 |
14 |
|
1-2 Female |
156 |
170 |
187 |
|
14 |
17 |
|
3-0 Female |
177 |
194 |
212 |
|
17 |
18 |
|
3-1 Female |
168 |
- |
- |
158 |
- |
- |
|
3-2 Female |
166 |
187 |
200 |
|
21 |
13 |
- = Animal dead
Individual Body Weights and Body Weight Changes - 2000 mg/kg
Dose Level mg/kg |
Animal Number and Sex |
Body Weight (g) at Day |
Body Weight (g) |
Body Weight Gain (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
|||
2000 |
2-0 Female |
161 |
- |
- |
154 |
- |
- |
2-1 Female |
164 |
- |
- |
158 |
- |
- |
|
2-2 Female |
158 |
- |
- |
156 |
- |
- |
-= Animal dead
Individual Necropsy Findings - 300 mg/kg
Dose Level |
Animal Number |
Time of Death |
Macroscopic Observations |
300 |
1-0 Female |
Killed Day 14 |
No abnormalities detected |
1-1 Female |
Killed Day 14 |
No abnormalities detected |
|
1-2 Female |
Killed Day 14 |
No abnormalities detected |
|
3-0 Female |
Killed Day 14 |
No abnormalities detected |
|
3-1 Female |
Found dead Day 1 |
Liver: patchy pallor Kidneys: dark Gastric mucosa: epithelial sloughing Non-glandular epithelium of the stomach: hemorrhagic |
|
2-2 Female |
Killed Day 14 |
No abnormalities detected |
Individual Necropsy Findings - 2000 mg/kg
Dose Level |
Animal Number |
Time of Death |
Macroscopic Observations |
2000 |
2-0 Female |
Found dead Day 1 |
Liver: patchy pallor Kidneys: pale Gastric mucosa:hemorrhagic epithelial sloughing |
2-1 Female |
Humanely killed Day 0 |
Liver: pale Kidneys: pale Stomach: clear liquid present Gastric mucosa: epithelial sloughing |
|
2-2 Female |
Humanely killed Day 0 |
Liver: pale Kidneys: pale Stomach: clear liquid present Gastric mucosa: epithelial sloughing |
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was approximately 500 mg/kg body weight (Globally Harmonized Classification System – Category 4, >300 - 2000 mg/kg body weight and is also according to the EU C&L rules).
The test item was also classified as Category 4 according to Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures. It is reasonable to assume that the Signal Word “Warning” and the Hazard Statement “H302: Harmful if swallowed” are therefore required. - Executive summary:
The acute oral toxicity of the test substance, TM 11-213, was assessed according to OECD TG 423 using Wistar rats. At 300 mg/kg bw one animal died at the next higher dose of 2000 mg/kg bw all animals died, within the first day. At macroscopy pale liver and kidneys were observed and effects in the gastrointestinal tract indicating severe irritation: fluid in the stomach and sloughing in the epidermis. The toxicity of this substance is somewhat unexpected. Other hydrocarbon aldehydes of similar C-atoms have toxicity > 2000 mg/kg bw. When using the scheme in the guideline for this substance an LD50 of 500 mg/kg bw is derived.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.